CHARLOTTE, N.C., Jan. 7, 2008 (PRIME NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that last month it initiated a Phase II trial of Droxidopa, an orally active synthetic precursor of norepinephrine, in patients with intradialytic hypotension (IDH).
The double-blind, placebo controlled trial, being conducted at 15 sites in the United States, is a dose response study comparing 400mg and 600mg of Droxidopa to placebo in a total of 75 patients. Following a two-week run-in period to establish baseline, patients in this 3-arm study will receive a single oral dose of Droxidopa or placebo 1 hour prior to each dialysis treatment over a four-week period (approximately 12 dialysis sessions). The study will compare the change in mean blood pressure and symptomatic improvement during the final two weeks of treatment to baseline established prior to drug treatment.
"Given its demonstrated success in treating the symptoms associated with hypotension in hemodialysis patients in Japan, we are pleased to have begun our Phase II dose response study here in the U.S.," commented Dr. Simon Pedder, Chelsea's President and Chief Executive Officer. "There is a significant unmet market need for a safe and effective treatment for hypotension associated with dialysis. Based on the robust data generated to date, we believe Droxidopa will prove to be a meaningful treatment option alleviating not only serious adverse events and complications associated with intradialytic hypotension, but also the disruption and repetition of dialysis sessions experienced by these patients."
Droxidopa is the Company's most advanced investigational product and is currently in development for the treatment of neurogenic orthostatic hypotension (NOH) as its lead indication. Chelsea plans to seek its first marketing approval for Droxidopa in NOH following the completion of its pivotal Phase III program in late 2008. Chelsea currently has U.S. sites open and actively screening patients for its pivotal Phase III program.
About Droxidopa and Intradialytic Hypotension (IDH)
Intradialytic hypotension, or IDH, is the most common adverse event during routine hemodialysis. IDH is often defined as a decrease in systolic blood pressure by 20 mm Hg or a decrease in mean arterial pressure by 10 mm Hg. IDH has been reported in approximately 25% of all hemodialysis patients, with elderly patients reporting higher incidences. Many adverse hemodialysis events, including headaches, lightheadedness, nausea, cramps, and seizures, are associated with IDH. These complications can routinely interrupt dialysis sessions, resulting in insufficient uremia toxin removal and necessitating repetition of the procedure. Interruptions due to IDH increase the costs of both the dialysis treatment sessions and the long-term care of less healthy hemodialysis patients.
Pivotal clinical studies conducted by DSP have demonstrated the efficacy of Droxidopa in the treatment of vertigo, dizziness and weakness associated with hypotension in hemodialysis patients. Subsequently, in 2000, after showing benefit in clinical trials, DSP received expanded marketing approval in Japan for this indication.
About Chelsea Therapeutics
Chelsea Therapeutics is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases. The Company is currently developing a library of metabolically inert antifolate compounds engineered to have potent anti-inflammatory and anti-tumor activity to treat a range of immunological disorders. Early clinical data suggests that Chelsea's lead antifolate compound, CH-1504, is a safe and effective treatment alternative to methotrexate for RA and may have further applications for psoriasis, IBD and certain cancers. Chelsea's antifolate program is complemented by a strategic partnership with Active Biotech AB for the joint development of a portfolio of therapeutics targeting immune-mediated inflammatory disorders and transplantation. In addition to its autoimmune pipeline, Chelsea is developing Droxidopa, an orally active synthetic precursor of norepinephrine, for the treatment of neurogenic orthostatic hypotension. Currently approved and marketed in Japan, Droxidopa has accumulated over 15 years of proven safety and efficacy, historically generating annual revenues of approximately $50 million in Japan.
This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include reliance on collaborations and licenses, risks and costs of drug development, regulatory approvals, intellectual property risks, our reliance on our lead drug candidate CH-1504, our history of losses and need to raise more money, competition, market acceptance for our products if any are approved for marketing, reliance on key personnel including specifically Dr. Pedder, management of rapid growth, and the need to acquire or develop additional products.